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Results For "Facility"

1627 News Found

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA
Drug Approval | July 11, 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product


Sigachi updates on fire accident at its Pashamylaram Facility, Telangana
News | July 04, 2025

Sigachi updates on fire accident at its Pashamylaram Facility, Telangana

The company has confirmed that the deceased are 39


Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
Drug Approval | June 23, 2025

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days


USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
Drug Approval | June 17, 2025

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations


Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh
News | June 13, 2025

Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh

The project will be instrumental in enhancing the company's API manufacturing capacity and global reach


Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa
Drug Approval | June 12, 2025

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar


Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification
News | May 28, 2025

Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification

Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs


Wanbury's Tanuku facility granted GMP certificate by ANVISA
Drug Approval | May 13, 2025

Wanbury's Tanuku facility granted GMP certificate by ANVISA

The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)


USFDA inspection at Concord Biotech’s API facility at Dholka
Drug Approval | May 03, 2025

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity